The US Food and Drug Administration (FDA) has issued a warning
to consumers that Reumofan Plus
, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be very harmful.
Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites.
According to the manufacturer
of the dietary aid “Reumofan Plus is a supplement that works like a pro in managing and conquering all kinds of pain caused by arthritis.”
have reported that the FDA announcement comes after an FDA approved laboratory conducted analysis on the supplement. The analysis showed that Reumofan Plus contained chemicals called Diclofenac Sodium and Methocarbamol. These two chemicals are classed as prescription only drugs and are not intended to be in the dietary supplement, according to the Sacramento Bee
Diclofenac Sodium, according to an FDA press follow-up note
, is a prescription non-steroidal anti-inflammatory drug that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines,.
Methocarbamol is a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.
The analysis was undertaken following reports received by the FDA about adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.
The FDA has recommended that consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately and to notify the FDA
This news story highlights the dangers of non-prescription natural medical cures. In a separate FDA report
on this subject, the following advice is outlined:
“Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs, says consumers should avoid products marketed as supplements that claim to have any effects that are the same as those of prescription drugs.
Fabricant says consumers should also be wary of products in which the important information on the label appears only in a foreign language. (Reumofan Plus and Reumofan Plus Premium are labeled in Spanish, but other versions of these products with labels in English may exist.)”
This incident follows a recent report on the Digital Journal
about some dietary supplements which were contaminated with Salmonella bacteria.